Comparison · NCT01101334-sae
CS-7017 Plus Erlotinib vs Erlotinib: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. CS-7017 Plus Erlotinib vs Erlotinib: serious adverse events. Trial comparisons, record NCT01101334-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01101334-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.545 | 0.401 | 0.683 | wilson | |
| Risk in group 2 | 0.356 | 0.232 | 0.502 | wilson | |
| Risk difference, group 1 minus group 2 | 0.19 | -0.0158 | 0.375 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.53 | 0.952 | 2.47 | log | |
| Odds ratio, group 1 over group 2 | 2.18 | 0.928 | 5.1 | log | |
| Number needed to harm, for one more participant with a serious adverse event on CS-7017 Plus Erlotinib than on Erlotinib | 5.27 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | CS-7017 Plus Erlotinib | Participants who received two 0.25 mg CS-7017 tablets administered twice daily and one 150 mg erlotinib tablet administered once daily. | 24 | 44 | EG000 |
| Group 2 | Erlotinib | Participants who received one 150 mg erlotinib tablet administered once daily. | 16 | 45 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Treatment-emergent adverse event (TEAE) data were collected from time of signing the informed consent form to the end of study assessment and follow-up period (30 days after last dose of study drug), up to approximately 2.5 years.
Source ClinicalTrials.gov
Trial
- Title
- Study of Erlotinib With or Without Investigational Drug (CS-7017) in Subjects With Advanced Non-small Cell Lung Cancer
- NCT number
- NCT01101334
- Phases
- PHASE2
- Conditions
- Advanced Non-small Cell Lung Cancer (NSCLC)
- Interventions
- CS-7017, erlotinib
- Lead sponsor
- Daiichi Sankyo
- Results first posted
- 2020-06-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01101334?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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